Kornimate/medical-research-clean huggingface dataset:
onstep versus lichtenstein, the onli trial.

Conditions: Hernia, Inguinal; Chronic Pain

Summary: the objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (lichtenstein) compared with no mesh fixation (onstep). the study hypothesis is that a smaller proportions of patients operated without mesh fixation (onstep) will have chronic pain that impairs daily function.


Eligibility criteria:
inclusion criteria: * clinical diagnose of a primary groin hernia that requires surgical intervention. * eligible for procedure performed under general anesthesia exclusion criteria: * not able to understand danish, written and spoken. * emergency procedures * previous inguinal hernia on ipsilateral side. * asa score more than 3. * incarcerated or irreducible hernia. * local (site of surgery) or systemic infection. * contralateral hernia being operated at the same time or planned operated during follow-up. * other abdominal hernias being operated at the same time or planned operated during follow-up. * previous surgery that has impaired the sensation in the groin area. * bmi \> 40 or \< 20. * daily intake of alcohol \>5 units, 1 unit = 12g pure alcohol. * known disease that impairs central or peripheral nerve function. * concurrent malignant disease. * impairment of cognitive function (e.g. dementia). * chronic pain that requires daily medication. * mental disorder that requires medication.
the prevalence of the aortic to radial pressure gradient in states of shock, outside the context of cardiac surgery, a prospective study

Conditions: Shock

Summary: first described in cardiac surgery, the aortic to radial pressure gradient (atrap) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. the risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm. the atrap definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmhg on the systolic pressure, or a pressure difference on the mean pressure of 10mmhg, both measures realised by arterial canulation, and with a duration superior than 5 minutes. if this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work. the atrap is documented in septic shock with a prevalence between 21% and 27%. the atrap can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. but the prevalence and risks factors are barely unknowns in this situation. most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. some medical teams in cardiac surgeries, or in intensive care unit (icu) for the management of shocks used often radial and femoral arterial catheter. it seems there is no at risk for the utilisation of a radial and femoral arterial canulation. out of the situation of cardiac surgery, there is a lack of information of the atrap, the objective of the study is to evaluate the prevalence of the atrap in shock, out of the situation of cardiac surgery.


Eligibility criteria:
inclusion criteria: * age superior or equal 18 years * vasopressors support superior or equal 0.5 µg/kg/min of equivalent norepinephrine * invasive monitoring of blood pressure with a radial arterial catheter and a femoral arterial catheter decided by de physician * beginning of the shock less than 48 hours. * consent exclusion criteria: * perioperative of cardiac surgery (between the beginning of the surgery and 7 days after) * pregnant woman or breast-feeding * major person under protection * person with privation of liberty by a justice decision, or an administrative decision

Keywords: radial artery femoral artery norepinephrine equivalent intensive care unit
pathway to diagnosis of ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to describe the prediagnostic symptoms and the events along the pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.


Eligibility criteria:
inclusion criteria: * histological diagnosis of ovarian cancer * indication for chemotherapy * age \> 18 years * signed informed consent exclusion criteria: * previous chemotherapy * unable or unwilling to participate in interview

Keywords: prediagnostic symptoms sentinel events pathway to diagnosis
zonulin biomarker for diagnosis of hip and knee infections

Conditions: Surgical Site Infection; Zonulin

Summary: prior studies investigating the etiopathogenesis of surgical site infection (ssi) traditionally suggested three main ways for the infection to occur: local contamination occurring during the surgery, hematogenous translocation of bacteria during concomitant bacteraemia, and contamination from adjacent infected tissues by the progression of the infective process. while most of the research on ssi focused on minimizing any source of pathogens at the time of the surgery, emerging evidence shows how acute and chronic ssi can emerge more often from bacteraemia or other tissues in the body, such as the gastrointestinal system, especially when dysbiosis and high permeability are retrieved. intercellular tight junctions (tjs) tightly regulate paracellular antigen trafficking. tjs are extremely dynamic structures that operate in several critical functions of the intestinal epithelium under both physiological and pathological circumstances. this paradigm was subverted in 1993 by the discovery of zonula occludens 1 (zo-1) as the first component of the tj complex 11 now being comprised of more than 150 proteins, including occludin, claudins, junctional adhesion molecules (jams), tricellulin , and angulins . however, despite major progress in our knowledge on the composition and function of the intercellular tj, the mechanisms by which they are regulated are still incompletely understood. one of the breakthroughs in understanding the role of gut permeability in health and disease has been the discovery of zonulin, and the only physiologic intestinal permeability modulator described so far. since then, zonulin has been used as a marker for increased intestinal permeability and associated with soluble cd14 (scd14) and lipopolysaccharide (lps), other common markers associated with surgical complication, inflammation, and bacterial translocations. as such, zonulin could be a biomarker for mid- and long-term complications after total joint replacement such as infection, loosening, and mechanical complications associated with painful symptomatology.


Eligibility criteria:
inclusion criteria: * patients who underwent primary or aseptic revision total hip and knee arthroplasty. * patients who underwent revision total hip and knee arthroplasty for infective reasons * patients 18 years of age or older exclusion criteria: - patients younger than 18 years old
bedside inoculation of ascitic fluid in diagnostic paracentesis

Conditions: Ascites; Peritonitis

Summary: this study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab as compared to current culture media standard, bedside inoculation with blood culture bottles.

the purpose of this study is to validate the principal study that recommends inoculation with blood culture bottles at bedside versus lab inoculation (delayed inoculation) of ascitic fluid in the diagnosis of spontaneous bacterial peritonitis. this study had a small sample size (29) and goal is to validate results with a larger sample size. the aim of current proposed study is to assess for non inferiority of lab inoculation of ascitic fluid culture versus current standard of blood culture bottles. to achieve 90% power and true sensitivity 95%, goal is to enroll 460 patients within the course of a year or until number of samples is reached, with plan to compare the sensitivity of bedside inoculation of blood culture bottles versus the lab using sterile plate techniques as per current lab culture technique. unlike previous study, all comers for ascitic fluid collected will be analyzed that are to undergo diagnostic paracentesis.

Eligibility criteria:
inclusion criteria: * ascites on ultrasound exclusion criteria: * consent declined
phase i/ii clinical trial of np41 for cranial nerve fluorescence imaging

Conditions: Cranial Nerve Injuries

Summary: preclinical evidence has shown that np41 is a novel nerve-binding peptide with safe pharmacokinetics. fluorescently labeled np41 is effective for the intraoperative visualization of cranial nerves during neurosurgery. this phase i/ii clinical trial is aimed to investigate the safety and validity of fam-np41 for the fluorescence imaging of cranial nerves. in the phase i trial, biological safety and adverse events will be evaluated, and pharmacokinetic parameters will be measured. in the phase ii trial, the sensitivity and specificity of fam-np41 for the fluorescence imaging of cranial nerves will be investigated, and the signal-to-background ratio will be calculated.


Eligibility criteria:
inclusion criteria: 1. enhanced brain mri with or without cranial ct confirms a diagnosis of tumor in the anterior skull base, the middle cranial fossa, or the posterior cranial fossa. structural images, dti sequences and 3d-ciss sequences confirm that the tumor is adjacent to the cranial nerve or the cranial nerve will be exposed during the neurological surgery. 2. the body weight is within ±20% of standard body weight \[0.7×(height cm-80)\]kg; 3. the preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range; 4. be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent. exclusion criteria: 1. preoperative hepatorenal insufficiency: alt or ast increased ≥ 2 times than the upper limit of normal range; serum creatinine \> 2.0 mg/ dl (177 μmol/l) or glomerular filtration rate \> 30 ml/min×1.73 m2; 2. positive reaction in the allergy test, or allergic constitution (such as allergic to two or more foods/drugs, or known to be allergic to protein or to this polypeptide); 3. preoperative imaging data (enhanced mri) are incomplete; 4. serious primary diseases involving important organs; 5. mentally or physically disabled patients; 6. alcohol abuse or long-term medication may affect the drug metabolism; 7. according to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition); 8. primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc. 9. female patients undergoing neurosurgery during pregnancy or lactation.

Keywords: cranial nerve neurosurgery fluorescence imaging molecular probe np41
effect of oral procaterol on postinfectious persistent cough

Conditions: Cough

Summary: the purpose of this study is to investigate the effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (urti).

persistent cough following upper respiratory tract infection (urti) is a common problem in the clinical practice, namely post-infectious cough. the potential mechanisms are viral-induced airway epithelial damage that leads to 1) airway hyperresponsiveness and airway narrowing, 2) increase in vascular permeability resulting in airway edema, and 3) activation of inflammatory mediators from inflammatory cells resulting in airway smooth muscle contraction. it is usually spontaneously resolved, although various therapeutic trials have been used with unpredictable results. regarding to bronchodilators, inhaled ipratropium was effective in reducing cough symptom in a small study (n=14). we conduct a double-blind randomized placebo-controlled trial to investigate the effectiveness of oral procaterol, as a bronchodilator, in non-asthmatic adult patients suffering from persistent cough post urti. eligible patients who have cough lasting longer than 3 weeks post urti with normal spirometry will be randomized to receive either placebo or procaterol (25 microgram twice daily) for 4 weeks. the primary outcome is cough symptom score using leicester cough questionnaire (lcq). the secondary outcomes are pulmonary function tests (spirometry, impulse oscillometry) and exhaled nitric oxide and quality of life (sf-36). all outcomes are measured at baseline, 2 weeks, and 4 weeks. bronchoprovocation test with methacholine is performed at baseline and 4 weeks to determine the provocative concentration of methacholine that induces falling of fev1 \>or =20%. adverse events will be recorded every visit. data analysis will be in both intention-to-treat and per-protocol fashion. a linear mixed-effect regression model will be applied to assess treatment effect on lcq score, sf-36, and lung function. within-subject variation will be fitted in the model as random effects whereas the treatment will be considered as a fixed effect. time at measurement (i.e., 2- and 4-week) will also be included in the mixed model by treating it as fixed-effect. marginal treatment effects between treatments and time will be then estimated and compared.

Eligibility criteria:
inclusion criteria: 1. having persistent cough that lasts longer than 3 weeks following urti 2. currently being a non-smoker 3. having normal spirometry (fev1\>or= 80% predicted) 4. obtain consent form exclusion criteria: 1. having cough more than 8 weeks 2. having history of allergic or intolerance to β2 agonist 3. having diagnosis of asthma by physicians 4. presence of wheeze or rhonchi on physical examination 5. having radiographic evidence of pneumonia, tuberculosis or sinusitis 6. having significant gastroesophageal reflux symptoms suggested by gerd-q questionnaire (gerd-q score \> 8) 7. currently taking ace-inhibitor 8. being active smokers 9. refuse to participate in the study

Keywords: postinfectious cough, postviral cough
evaluation of root resorption following different mandibular incisors intrusive mechanics

Conditions: Orthodontic Tooth Movement; Intrusion of Tooth; Resorption, Root

Summary: evaluation of root resorption following different mandibular incisors intrusive mechanics : a randomized clinical trial


Eligibility criteria:
inclusion criteria: * patient will be included in this study if has: * an age range between 12 and 16 years. * deep overbite with excessive curve of spee of more than 5mm * over erupted lower incisors. * permanent teeth are all present (except for third molar). * no previous orthodontic treatment. * no indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination exclusion criteria: * patients who needed surgery to fix skeletal problems. * any previous trauma or root canal therapy * missing lower incisor. * patients with congenital dentoskeletal disorders

Keywords: intrusion root resorption cone beam computed tomography utility arch nitinol reverse curve wire miniscrew mandibular incisors
evaluation of safety and exploratory efficacy of an autologous adipose-derived cell therapy product for treatment of single knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (ibp), psc-01, the patient's own adipose-derived stromal vascular fraction cells (svf) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. the secondary objective is to get initial data on efficacy of the psc-01.


Eligibility criteria:
inclusion criteria: * if a woman of childbearing potential, the study participant must not be pregnant at the time of consent and must take contraceptive measures to prevent a pregnancy while actively participating in the study * the study participant may be of any gender or ethnic background. * must experience knee pain at least weekly for at least 3 months. * must have failed a minimum of 6 weeks of first line, conservative therapy * demonstrated clinical and radiographic evidence of oa diagnosis * grade 2, 3, or 4 kellgren-lawrence score in one knee. * normal or within protocol approved limits of laboratory blood and urinalysis tests * must be suitable for cellular therapy per the investigator's opinion * must be suitable for liposuction per the investigator's opinion * must possess the cognitive ability to understand the investigational nature of this clinical trial and voluntarily provide consent for study participation exclusion criteria: * evidence of oa in the contralateral knee with a kellgren-lawrence score greater than 2 * if a woman of child-bearing potential, the study participant must not be pregnant or attempt to become pregnant while actively taking part in the study. * steroid injection in either knee within 60 days of providing informed consent * the subject must not be diagnosed with any of the following diseases at the time of consent: * osteonecrosis * active autoimmune disease * serious cardiac condition * psychotic diseases * epilepsy * uncontrolled diabetes * prescribed immunosuppressive therapy at the time of consent * evidence of cancer at the time of consent * history of alcohol or substance abuse * regular smoker at the time of consent * received experimental medication or participated in another clinical study within 60 days of providing informed consent * concurrent diseases or circumstances that the investigator judges to be a potential risk to patient health or a confounding variable in the assessment of study endpoints.

Keywords: cellular therapy stromal vascular fraction svf koos autologous mesenchymal stem cell msc knee osteoarthritis adipose-derived mesenchymal stem cells ad-msc intraarticular
juvenile idiopathic arthritis in children in estonia.

Conditions: Epidemiology

Summary: aims of the study: * to study the incidence rate of juvenile idiopathic arthritis (jia) and it's clinical subtypes in estonia for the years 1998-2000; * to examine the course and short-term clinical outcome of jia. method: a prospective population-based study carried on in 14 counties of estonia


Eligibility criteria:
inclusion criteria: * the international league of associations for rheumatology (ilar) criteria for juvenile idiopathic arthritis * children aged 0-15 years who had arthritis of an unknown cause for at least six weeks with an onset of the disease during the study period exclusion criteria: * children with infectious arthritis, postinfectious arthritis, traumatic arthritis and systemic connective tissue diseases

Keywords: juvenile idiopathic arthritis incidence rate
the role of rotator interval closure in bankart lesion repair

Conditions: Bankart Lesions; Anterior Shoulder Instability

Summary: the null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. the investigators suspect that patients who undergo a bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a bankart lesion repair alone. no difference will be observed for recurrence rate between the two treatment groups

research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for bankart lesions and anterior shoulder instability. to date there is only weak evidence supporting the superiority of bankart lesion repair in addition to rotator interval closure compared to bankart lesion repair alone. does bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with bankart lesions who are treated with bankart lesion repair alone?

Eligibility criteria:
inclusion criteria: * patients between the ages of 15 to 50 years * at least one episode of demonstrated dislocation * bankart lesion of the anterior glenoid labrum * absence of other capsular and tendon injuries * absence of glenoid fractures or divots exclusion criteria: * posterior instability or the need for posterior surgical reconstruction * significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (hill-sachs lesions) * presence of other pathologic conditions of the shoulder (excluding slap lesions)

Keywords: shoulder bankart anterior instability rotator cuff
prediction to detect pre-dm/dm in a chinese population

Conditions: Diabetes Mellitus

Summary: this project will compare the sensitivity and specificity of different screening criteria or recommendations to detect pre-diabetes or diabetes mellitus in a chinese population, using point-of-care hemoglobin a1c.


Eligibility criteria:
inclusion criteria: * age ≥25 years old * with no previous diagnosis of dm * chinese. exclusion criteria: * a history of cardiovascular diseases including any type of stroke, ischemic heart disease, atrial fibrillation, and/or peripheral vascular disease * severe mental or physical disease or language barriers that limited data collection